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The PositionProduct Lead CGM External Manufacturing (m/f/d) is a global function within Near Patient Care Operations. CGM External Manufacturing is responsible for managing all external manufacturing partners to deliver finished and semi-finished goods in quality and time for our Continuous Glucose Monitoring (CGM) business, which includes the development, implementation and scaling of external manufacturing processes and production and test equipment.
Your opportunity While being part of an aggressive capacity extension program, you are accountable to establish production capacity at our external supplier together with their sub-suppliers. You are familiar with high-volume electromechanical automation projects and always are on top of the project progress and the remaining risks.
You are capable of understanding the technical details to give direction, drive decisions and keep the project on track. You enjoy finding solutions where others see problems and successfully leverage the expertise within and outside of Roche while keeping our partners accountable against their contractual obligations. You build rapports and are capable of communicating on different hierarchical levels, set clear expectations and targets and give feedback on the performance to develop the relationship.
You drive product care activities to enable robust project and product delivery and are familiar with product change processes, issue resolution, complaint management, CAPA and SCAR processes. You interact with different functions such as development, procurement, quality and regulatory to enable your ownership for the product and the production process, ensuring and maintaining regulatory compliance with the relevant interfaces. You are capable of explaining and defending "freedom to operate" in a product audit.
For future product variants and production processes, you are capable to develop automation and production concepts and drive the identification of the right strategic partners together with relevant interfaces and initiate and implement. You take the manufacturing perspective within the development projects to enable cost efficiency and are responsible for the design transfer to the external supplier establishing a robust and scalable production process and the corresponding equipment, ensuring design to quality and manufacturability.
Who you are University Degree, e.g. in Engineering, Science or closely related scientific/technical discipline.
5-7 years experience in project, product and technical partner management.
Experience in manufacturing technologies (e.g. high-volume assembly automation and testing of electromechanical parts), technical project and supplier management, product care and product development of medical devices or IVD and the corresponding regulatory environment and quality systems.
Proven leadership in building, managing and developing multidisciplinary teams in a global environment with excellent interpersonal and communication skills capable to collaborate from shop floor to senior management.
Strong analytical skills and able to set priorities, drive decisions and resolve problems and conflicts, adapt to changes, deal with ambiguity and cope with pressure with strong business and finance acumen and strategic thinking and acting.
Fluent in English and German on a business level with excellent verbal and written skills is required.
Willingness to travel mainly within Europe and potentially North America.
Location: Mannheim or Rotkreuz.
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